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The aim of this clinical study is to assess the long-term efficacy and safety of BCD-132 (divozilimab) in patients with multiple sclerosis who previously participaded in BCD-132-2 and BCD-132-4/MIRANTIBUS studies
Clinical study BCD-132-EXT is a Phase III study extension conducted after completion of BCD-132 500 mg therapy by subjects of clinical studies BCD-132-2 and BCD-132-4/MIRANTIBUS.
The study is designed as a multicenter, open-label, non-randomized, non-comparative, single-arm clinical study.
The study consists of a screening period (14 days), a treatment period (96 weeks) and a follow-up period (4 weeks). During treatment period, the subjects will receive the investigational product BCD-132 (divozilimab).
The duration of participation for each subject will be approximately 102 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BCD-132 (divozilimab) | Experimental | Intravenous infusion of BCD-132 every 24 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Divozilimab | Biological | Intravenous infusion of BCD-132 every 24 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Annualized relapse rate | 48 and 96 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Time to first relapse | 102 weeks | |
| Proportion of patients without confirmed relapses | 48 and 96 weeks | |
| Total number of T1 Gd+ lesions (per scan) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vyacheslav Andreyevich Dudin | Kirov | Russia | ||||
| Dmitry Vladimirovich Pokhabov |
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| 48 and 100 weeks |
| Proportion of patients without contrast-enhancing lesions | 48 and 100 weeks |
| Proportion of patients without new or enlarging T2 lesions | 48 and 100 weeks |
| Number of new or enlarged T2 lesions | 48 and 100 weeks |
| Number of CUA (Combined Unique Active) lesions | Total number of new contrast-enhancing T1 lesions and new T2 lesions or enlarged T2-weighted lesions without double counting on MRI (Combined Unique Active) | 48 and 100 weeks |
| Changes over time in neurological deficit parameters according to the Expanded Disability Status Scale (EDSS) | 102 weeks |
| Changes over time in Timed 25-Foot Walk Test | 102 weeks |
| Changes over time in 9-Hole Peg Test | 102 weeks |
| Changes over time in Symbol Digit Modalities Test (SDMT) | 102 weeks |
| Changes over time in quality of life indicators assessed with the SF-36 questionnaire | 102 weeks |
| Krasnoyarsk |
| Russia |
| Ivan Aleksandrovich Shchukin | Moscow | Russia |
| Sergey Viktorovich Kotov | Moscow | Russia |
| Elena Vladimirovna Parshina | Nizhny Novgorod | Russia |
| Irina Aleksandrovna Sokolova | Nizhny Novgorod | Russia |
| Gennady Nikolayevich Mishin | Pyatigorsk | Russia |
| Yuri Vladimirovich Trinitatsky | Rostov-on-Don | Russia |
| Zoya Aleksandrovna Goncharova | Rostov-on-Don | Russia |
| Leonid Grigoryevich Zaslavsky | Saint Petersburg | Russia |
| Natalya Agafonovna Totolyan | Saint Petersburg | Russia |
| Irina Yevgenyevna Poverennova | Samara | Russia |
| Valentina Mikhaylovna Alifirova | Tomsk | Russia |
| Stella Anatolyevna Sivertseva | Tyumen | Russia |
| Irina Vladimirovna Greshnova | Ulyanovsk | Russia |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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